Semaglutide, oral — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Semaglutide, oral as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Nausea | 20.0 | 2.4 | +17.6 | PIONEER 1 (14 mg, 26 weeks) |
| Diarrhoea | 9.0 | 2.4 | +6.6 | PIONEER 1 |
| Vomiting | 7.0 | 1.2 | +5.8 | PIONEER 1 |
| Decreased appetite | 7.0 | 1.6 | +5.4 | PIONEER 1 |
| Discontinuation for adverse events | 7.3 | 2.4 | +4.9 | PIONEER 1 |
| Nausea | 36.5 | 12.2 | +24.3 | OASIS 1 (50 mg) |
| Vomiting | 24.6 | 4.2 | +20.4 | OASIS 1 |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- As for subcutaneous semaglutide
- Inability to comply with the fasted administration requirement, which materially reduces exposure
§4.3Warnings and precautions
- All warnings applicable to subcutaneous semaglutide apply
- Exposure is unusually sensitive to administration conditions; taking the tablet with food or more than 120 mL of water can reduce absorption to a degree that abolishes the therapeutic effect
- Levothyroxine exposure is increased by approximately 33 % when co-administered
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, Jeppesen OK, Lingvay I, Mosenzon O, Pedersen SD, Tack CJ, Thomsen M, Vilsbøll T, Warren ML, Bain SC. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. New England Journal of Medicine 2019;381(9):841–851. doi:10.1056/NEJMoa1901118 · PMID 31185157
- Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzík M. PIONEER 1: randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes. Diabetes Care 2019;42(9):1724–1732. doi:10.2337/dc19-0749 · PMID 31186300
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